Kofal Fuerte Rojo 4 Oz (wp)(da)

Kofal Fuerte Rojo 4 Oz (wp)(da)
SPL v6
SPL
SPL Set ID 98488a07-eba0-2b4e-e053-2995a90ad6ab
Route
TOPICAL
Published
Effective Date 2018-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 g)
Inactive Ingredients
Glyceryl Monostearate Propylparaben Water Trolamine Paraffin Eucalyptus Oil Menthol, Unspecified Form Stearic Acid Camphor, (-)- Cetyl Alcohol Methylparaben Polysorbate 20

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-12-03 Until 2027-10-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Use

For the temporary relief of minor aches and pains of muscles and joints associated with

  • backaches
  • arthritis
  • strains
  • bruises
  • sprains

Do Not
  • apply to wounds or damaged skin
  • bandage tightly
Section 55105-1
Active ingredient Purpose
Mythyl Salicylate 15% Topical analgesic
Warnings

For external use only. Avoid contact with the eyes

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor
Drug Facts

Drug Facts

Other Information
  • store in a cool dry place between (59-86°F)15-30°C
  • don’t use if seal over jar is broken, torn, or missing
Principal Display Panel

KOFAL ® Fuerte

Deportistas - Athletes

Pain relieving ointment

Pomada analgesico

4 oz (113 g)

Stop Use and Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out of Reach of Children

If swallowed, get medical help, or contact a Poison Control Center immediately.

If Pregnant Or Breast Feeding,

ask a health professional before use.


Structured Label Content

Use

For the temporary relief of minor aches and pains of muscles and joints associated with

  • backaches
  • arthritis
  • strains
  • bruises
  • sprains

Do Not (Do not)
  • apply to wounds or damaged skin
  • bandage tightly
Section 55105-1 (55105-1)
Active ingredient Purpose
Mythyl Salicylate 15% Topical analgesic
Warnings

For external use only. Avoid contact with the eyes

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor
Drug Facts

Drug Facts

Other Information (Other information)
  • store in a cool dry place between (59-86°F)15-30°C
  • don’t use if seal over jar is broken, torn, or missing
Principal Display Panel

KOFAL ® Fuerte

Deportistas - Athletes

Pain relieving ointment

Pomada analgesico

4 oz (113 g)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help, or contact a Poison Control Center immediately.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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